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Cortex - Life Sciences Insights

| 2 minutes read

Australia’s TGA considers stronger nicotine vaping product regulation

On 23 March 2023, Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) published a summary of feedback received from a public consultation, initiated in November 2022, on potential reforms to the regulation of nicotine vaping products (NVPs) in Australia.  

The TGA received over 4,000 responses to its call for comment regarding the following issues:

  • strengthening border controls for NVPs;
  • requiring pre-market TGA assessment of NVPs against minimum quality and safety standards;
  • requiring minimum quality and safety standards for NVPs; and
  • clarifying the status of NVPs as therapeutic goods.

Current regulation of NVPs

Currently, NVPs are regulated as medicines under the Therapeutic Goods Act 1989. This means that NVPs cannot be imported, manufactured or supplied (excluding retail supply) unless they are listed on the Australian Register of Therapeutic Goods (ARTG).

Current smokers can obtain NVPs solely to assist in quitting smoking, following a consultation with a medical practitioner and a prescription from a medical practitioner. A person with a prescription can directly import up to 3 months’ supply of NVPs for personal use.

NVPs can only be lawfully supplied by pharmacies in Australia. It is illegal for other Australian retailers (such as tobacconists, ‘vape’ shops and convenience stores) to sell NVPs to consumers, even where the consumer has a valid doctor’s prescription. Nevertheless, vaping products, including NVPs are readily available (illegally) from a large number of convenience and other stores throughout Australia, and are being purchased by minors.

Feedback on the proposed reforms 

  1. Strengthening border controls for NVPs:

The TGA’s preferred option for reform regarding this issue was to end the personal importation scheme and require importers to obtain an import permit.  This was supported by all Australian State/Territory governments and an overwhelming number of public health associations, health professional bodies and individuals. Should this proposal be adopted, any NVPs attempted to be imported without the appropriate import permit would be illegal and any that are identified by Australian Border Force would be seized. Penalties would also apply to the importers.

Many groups also noted that border controls should be placed on non-nicotine vaping products (which was broader than the scope of the consultation).

2. Requiring pre-market TGA assessment of NVPs against minimum quality and safety standards:

The TGA’s preferred option was to require pre-market TGA assessment of NVPs against a product standard specifying certain quality and safety requirements. This was supported by a significant number of State/Territory governments and health professional bodies and individuals.

3. Requiring minimum quality and safety standards for NVPs:

The TGA’s preferred option was to include pharmaceutical-like packaging, warning statements, prohibition or restriction on flavours and certain other ingredients and limits on NVP volume and overall nicotine content.

This was strongly supported by State/Territory governments, health professional bodies and individuals.  There was also significant support for banning disposable NVPs.

4. Clarifying the status of NVPs as ‘therapeutic goods’:

This was generally supported (except by vaping retailers / manufacturers / importers, pro-vaping associations and individual vapers).

Next steps

The TGA has considered the feedback and is now providing advice to the Government on possible options for reform.  The Government will then consider the TGA consultation and advice and implement any legislative changes.